Device Classification Name |
Electrode, Pacemaker, Temporary
|
510(k) Number |
K040812 |
Device Name |
DETECT SURGICAL PACING AND MAPPING TOOL |
Applicant |
MEDTRONIC VASCULAR |
1015 GRAMSIE RD |
SHOREVIEW,
MN
55126 -3082
|
|
Applicant Contact |
EDWARD VALDEZ |
Correspondent |
MEDTRONIC VASCULAR |
1015 GRAMSIE RD |
SHOREVIEW,
MN
55126 -3082
|
|
Correspondent Contact |
EDWARD VALDEZ |
Regulation Number | 870.3680
|
Classification Product Code |
|
Date Received | 03/29/2004 |
Decision Date | 09/02/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|